Lengthy earlier than the Supreme Court docket determined Dobbs v. Jackson Ladies’s Well being Org., 142 S. Ct. 2228 (2022), Bexis was involved that FDCA preemption could be dragged into the nation’s tradition wars by the abortion subject.  He hoped the Supreme Court docket would adhere to long-established precedent and thus maintain FDCA preemption out of politics and in product legal responsibility litigation the place it belonged.  Dobbs extinguished that hope (and lots of others), so Bexis determined that he may as nicely embrace the inevitable.

He proposed writing his personal legislation evaluate article on this topic – about which he is aware of as a lot as anybody – to the Meals & Drug Legislation Institute.  FDLI accepted the proposal, and now, over a 12 months later, the article is now printed:  Beck, Danziger, Johansen & Hayes, “Federal Preemption & the Put up-Dobbs Reproductive Freedom Frontier,” 78(2) Meals & Drug L.J. 109 (2023).  The article is offered to the general public on the journal’s web site, right here.  Bexis hardly did this alone, being ably assisted by three (then) Reed Smith colleagues, Philip W. Danziger, Sarah B. Johansen, and Andrew R. Hayes.

Bexis concluded that three types of preemption, (1) impediment preemption below Buckman Co. v. Plaintiffs Authorized Committee, 531 U.S. 341 (2001), (2) impossibility preemption barring “cease promoting” claims below Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), and (3) categorical OTC drug preemption below 21 U.S.C. §379r, ought to preclude some (however hardly all) state abortion-related bans – notably when states purport to focus on the provision of FDA-approved medicine for his or her FDA-approved indications.  Right here’s the article’s summary:

Within the wake of the Dobbs resolution abolishing the constitutional proper to reproductive freedom, some states have enacted measures that may prohibit the importation, sale, and use of U.S. Meals and Drug Administration (FDA)-approved medicine (each prescription and OTC) which are a part of treatment abortion and emergency contraception medical remedies.  Opponents of such measures have raised the prospect of federal preemption below the Federal Meals, Drug, and Beauty Act (FDCA) in opposition to these enactments.

This paper discusses the 2 kinds of implied preemption that may be raised towards state bans and different restrictions of FDA-approved abortion-related prescribed drugs, in addition to attainable categorical preemption within the context of OTC medicine.  It examines prior preemption litigation involving affirmative state bans imposed towards FDA-approved merchandise.  It additionally addresses implied preemption below [Bartlett], of privately introduced “stop-selling” claims introduced towards numerous FDA-approved prescribed drugs within the product legal responsibility context.  The paper additionally discusses state management over medical apply within the context of off-label use of FDA-approved medicine to terminate being pregnant or to supply post-coitus contraception.

The paper concludes that these preemption arguments seem meritorious within the context of precise or de facto state bans on abortion-related medicine, a minimum of within the context of on-label use, with state management over off-label use being a weaker case. It factors out that these preemption arguments additionally place FDA at larger danger of political and judicial interference with its science-based requirements for approval of medicine and their meant makes use of.

Put up-Dobbs Federal Preemption, 78 Meals & Drug L.J. at 109.

The underside line – FDCA-related federal preemption is strongly pro-choice.  With that in thoughts, the multi-faceted assault straight towards the FDA’s regulatory authority within the Alliance for Hippocratic Medication litigation, that the Weblog has mentioned right here, right here, and right here, is solely comprehensible.  The anti-choice facet additionally understands that preemption is prone to preclude states from stopping entry to FDA-approved merchandise for his or her FDA-approved indications.  Therefore their drive to overturn FDA approval of mifepristone and different abortifacient medicine, or a minimum of to show again the FDA clock to forestall their use in telemedicine.  Telemedicine is the important thing, because it permits residents of even essentially the most anti-choice jurisdictions to entry mifepristone via interstate commerce.  That additionally explains why the Alliance plaintiffs sought to resurrect the nineteenth century Comstock Act – as a result of it offers an (albeit archaic) federal floor to assault interstate commerce in FDA-approved abortifacient medicine.

Bexis’ article addresses preemption, off-label use, and associated points with typical Bexis thoroughness.  If you interested by this space, test it out.